hamovigilance.pptx

Hemovigilance latest updates and information for medical hospitals

1. HaEMOVIGILANCE BY DR. PANKAJ MAHADKAR 1

2. CONTENT Introduction Centre's under HvPI Objectives of Haemovigilance Responsibilities of components of Haemovigilance Donor Haemovigilance Responsibilities of Donor Haemovigilance Summary 2

3. INTRODUCTION Haemovigilance is a continuous process of data collection and analysis of blood transfusion-related adverse reactions in order to investigate their cause and outcomes and to prevent their occurrence or recurrence.. It includes the identification, reporting, investigation, and analysis of adverse reactions and events in recipients and blood donors as well as incidents in manufacturing processes, eventually errors and “near-misses”. The Haemovigilance Programme of India (HvPI) was launched on 10th December, 2012 in the country. 3

4. OBJECTIVES OF HEMOVIGILANCE To improve patient and product safety . T o advance public policy concerning patient safety. Reporting can help in identifying hazards , and risks and provide information as to where the system is breaking down. T o reduce the likelihood of injury to future patients Reporting Suspected Adverse Reactions in a timely manner facilitates effective risk management. 4

5. Organization structure 5

6. 6

7. CENTRES UNDER HVPI Blood banks of Medical College Institutes Hospitals Stand alone blood centres 7

8. HAEMO-VIGIL SOFTWARE It is a Software which is being used for HvPI to collect & collate Transfusion Reaction Reports from Centres under HvPI for onward transmission of data to NCC. This software was indigenously developed by IT Team, NIB. launched on 24 th Jan, 2013 8

9. ROLES AND RESPONSIBILITIES OF COMPONENTS 9

10. 10

11. 11

12. 12

13. 13

14. 14

15. 15

16. MEDICAL AND OTHER BEDSIDE HEALTHCARE STAFF OF THE CENTRES Report Suspected Transfusion Reaction immediately to the attending Physician. Document the details of the patient as well as the implicated units/ products in the Form No. 1 and retain it in the patient's file. Send the details of the Transfusion Reaction to the Department of Transfusion Medicine/ Blood Centre in the Form No. 2 16

17. BLOOD CENTRES OF MEDICAL COLLEGE/ INSTITUTE/ HOSPITALS AND STAND-ALONE BLOOD CENTRES Centres in India that are registered with NCC- HVPI To enter the information regarding Transfusion Reactions in Haemo -Vigil Software for onward transmission of data to NIB, NCC- HvPI . 17

18. DEPARTMENT OF TRANSFUSION MEDICINE/ BLOOD CENTRE Reporting the details of the clinical and laboratory investigations to the respective medical ward and/or to the Hospital Transfusion Committee. To assess the Imputability levels of the adverse reactions in coordination with the attending Physician (Annexure V) 18

19. 19

20. Term Assessment Scale Definite (Certain) When there is conclusive evidence beyond reasonable doubt that the adverse event can be attributed to the transfusion Probable (Likely) When the evidence is clearly in favour of attributing the adverse event to the transfusion. Possible When the evidence is indeterminate for attributing the adverse event to the transfusion or an alternate cause. Unlikely (Doubtful) When the evidence is clearly in favour of attributing the adverse event to causes other than the transfusion. Excluded When there is conclusive evidence beyond reasonable doubt that the adverse event can be attributed to causes other than the transfusion. IMPUTABILITY LEVELS 20

21. To assure the completeness of the Transfusion Reaction-Traceability document (TR-TD) Record Report the details of transfusion as per the TRRF Form in the Haemo -Vigil Software. 21 DEPARTMENT OF TRANSFUSION MEDICINE/ BLOOD CENTRE

22. 22

23. HOSPITAL TRANSFUSION COMMITTEE To review the Reported Transfusion Reactions for improving Hospital Transfusion Practices as per institutional policy and terms of reference of Hospital transfusion Committee. 23

24. RESPONSIBILITIES OF NIB, NATIONAL CO-ORDINATING CENTRE Collection, collation & analysis of Haemovigilance data and forward it to MoH&FW . Compilation of data and flagging major issues for deliberation by the Haemovigilance Advisory Committee. To monitor the functioning of the Centres under HvPI & quality of the data received from the Centres under HvPI . Review completeness, quality check, causality assessment . 24

25. NIB, NATIONAL CO-ORDINATING CENTRE Preparation of SOPs, Guidance Documents and Training Manuals e.g. Software Manual etc. Providing training to the Centres under HvPI . Publication of Haemovigilance Newsletter . Communicate recommendations of Haemovigilance Advisory Committee to MoH&FW 25

26. RESPONSIBILITIES OF MOH&FW Forward recommendations from Haemovigilance Advisory Committee to MoH & MoH &FW RESPONSIBILITIES OF CDSCO Formulate safety related regulatory decisions. Communication of Blood and Blood Products Transfusion Safety related decisions to Stakeholders. 26

27. FLOW CHART FOR REPORTING ADVERSE REACTIONS ASSOCIATED WITH BLOOD TRANSFUSION 27

28. 28

29. 29

30. Donor haemovigilance 30

31. Introduction Donation of blood and blood components may sometimes result in a variety of adverse reactions in a few donors, and systemic surveillance of these donor adverse reactions (DARs) is known as Donor Haemovigilance The Donor Haemovigilance program's primary goal is to collect, analyse, and disseminate information on a pre-defined set of DARs. This programme was introduced in India on 14th June 2015 31

32. NATIONAL PROGRAMME OF DONOR HAEMOVIGILANCE Objectives Improve donor safety and satisfaction through monitoring, analysing, and researching adverse events Analyse risk factors, implement and evaluate preventive measures Provide evidence-based support for blood donation process improvement Reduce the frequency of adverse events Increase donation frequency 32

33. NATIONAL PROGRAMME OF DONOR HAEMOVIGILANCE Aims To increase the confidence of donors and improve blood donor safety Identifying the trends in adverse events and reactions Determining risk factors and raising awareness Providing evidence for the development and amendment of policies to improve practices Guiding research 33

34. PROCESS FLOW OF NCC FOR DONOR HAEMOVIGILANCE PROGRAMME 34

35. 35

36. Roles and Responsibilities of components 36

37. MEDICAL OFFICER OF DONATION CENTRE To correctly recognize the possible adverse reaction in a blood donor Fill out the Donor adverse reactions reporting form with the specifics of the adverse reaction. After an adverse reaction, manage and monitor the donor. Encourage blood donors to report any delayed adverse reactions after they leave the blood donation region. Educate the staff working in the donation area or the blood donation camp to correctly recognize the reaction/ event, manage the event and report to the blood center in charge. 37

38. BLOOD CENTRE OR DEPARTMENT OF TRANSFUSION MEDICINE To assure the completeness of donor adverse reaction reporting form To assess the imputability of the donor adverse reaction To report the details of adverse reaction as per the donor adverse reaction reporting form in the Donor Vigil Software To report the monthly details of the data like total collection, type of collection, type of donors, types of blood bag used, etc. To educate the staff and donors about the risk of an adverse event after a blood donation and the importance of reporting it to the national programme 38

39. NIB, NATIONAL CO-ORDINATION CENTRE- DONOR HVPI Review completeness, quality check, and causality assessment. Collection, collation, and analysis of donor Haemovigilance data and forward it to MoH & FW. Compilation of data and flagging major issues for deliberation by the Haemovigilance advisory committee. To monitor the function of centres under HvPI and quality of data received from the blood centres. 39

40. NIB, NATIONAL CO-ORDINATION CENTRE- DONOR HVPI Preparation of guidance documents and training manuals etc. Providing training to the centres under HvPI . Publication of Haemovigilance newsletters. Communicate recommendations of hemovigilance advisory committee to MoH & FW. 40